Nov 18 - 6:08
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued guidance on certain transitional provisions regarding European Union medical devices regulations. MDCG on Transitional Provisions ...
Oct 17 - 5:30
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745...
Oct 7 - 10:55
The MoH in Indonesia has released SIKLARA- a medical device risk classification system that lines up with AMDD. This system aims to be more user friendly, as well as support registrants in determining medical device...
Sep 19 - 6:04
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to...
Sep 13 - 4:10
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult...
